Design of the Lifestyle Interventions for severe mentally ill Outpatients in the Netherlands (LION) trial; a cluster randomised controlled study of a multidimensional web tool intervention to improve cardiometabolic health in patients with severe mental illness.

BACKGROUND: The cardiometabolic health of persons with a severe mental illness (SMI) is alarming with obesity rates of 45-55% and diabetes type 2 rates of 10-15%. Unhealthy lifestyle behaviours play a large role in this. Despite the multidisciplinary guideline for SMI patients recommending to monitor and address patients' lifestyle, most mental health care professionals have limited lifestyle-related knowledge and skills, and (lifestyle) treatment protocols are lacking. Evidence-based practical lifestyle tools may support both patients and staff in improving patients' lifestyle. This paper describes the Lifestyle Interventions for severe mentally ill Outpatients in the Netherlands (LION) trial, to investigate whether a multidimensional lifestyle intervention using a web tool can be effective in improving cardiometabolic health in SMI patients.

METHODS/DESIGN: The LION study is a 12-month pragmatic single-blind multi-site cluster randomised controlled trial. 21 Flexible Assertive Community Treatment (ACT) teams and eight sheltered living teams of five mental health organizations in the Netherlands are invited to participate. Per team, nurses are trained in motivational interviewing and use of the multidimensional web tool, covering lifestyle behaviour awareness, lifestyle knowledge, motivation and goal setting. Nurses coach patients to change their lifestyle using the web tool, motivational interviewing and stages-of-change techniques during biweekly sessions in a) assessing current lifestyle behaviour using the traffic light method (healthy behaviours colour green, unhealthy behaviours colour red), b) creating a lifestyle plan with maximum three attainable lifestyle goals and c) discussing the lifestyle plan regularly. The study population is SMI patients and statistical inference is on patient level using multilevel analyses. Primary outcome is waist circumference and other cardiometabolic risk factors after six and twelve months intervention, which are measured as part of routine outcome monitoring using standard protocols. Secondary outcomes include depressive and negative symptoms, cost-effectiveness, and barriers and facilitators in intervention implementation.

DISCUSSION: Adequate health care should target both mental health and lifestyle behaviours in SMI patients. This trial contributes by studying a 12-month multidimensional lifestyle intervention as a potential evidence based (nursing) tool for targeting multiple lifestyle behaviours in SMI patients.

TRIAL REGISTRATION: Nederlands Trialregister NTR3765 (trialregister.nl; registered 21 December 2012).